The following data is part of a premarket notification filed by Damor America, Inc. with the FDA for Damor Cream Saturated Dressing.
| Device ID | K891097 |
| 510k Number | K891097 |
| Device Name: | DAMOR CREAM SATURATED DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | DAMOR AMERICA, INC. DICKSTEIN, SHAPIRO & MORIN 8300 BOONE BLVD., SUITE 800 Vienna, VA 22180 |
| Contact | M Karny |
| Correspondent | M Karny DAMOR AMERICA, INC. DICKSTEIN, SHAPIRO & MORIN 8300 BOONE BLVD., SUITE 800 Vienna, VA 22180 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-08-25 |